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Data / Medical devices / System, Test, Rheumatoid Factor / United States

FDA-registered makers of System, Test, Rheumatoid Factor in the United States: 27 establishments

27 establishments in the United States are registered with the FDA to make System, Test, Rheumatoid Factor (product code DHR). 21 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
System, Test, Rheumatoid Factor
Product code
DHR
Country
United States

Makers of System, Test, Rheumatoid Factor in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer4April 17, 2019000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Manufacturer for export2November 25, 1996000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer2September 12, 1996000api.fda.gov
Theratest Laboratories, Inc.Lombard, IL, United StatesManufacturer2July 28, 1995010api.fda.gov
Zeus Scientific LLCBranchburg, NJ, United StatesManufacturer2February 27, 2004010api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer1January 15, 2003000api.fda.gov
Arlington Scientific, Inc.Springville, UT, United StatesContract manufacturer, Manufacturer1May 21, 1982000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1November 4, 1996040api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer1June 4, 1996000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer1June 4, 1996000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1May 21, 1982000api.fda.gov
Gold Standard Diagnostics, LLCDavis, CA, United StatesRepackager or relabeler, Specification developer1July 9, 2002000api.fda.gov
Immco Diagnostics, Inc.Williamsville, NY, United StatesManufacturer1September 23, 2015000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer1May 20, 2020000api.fda.gov
KSL Biomedical, Inc.Buffalo, NY, United StatesManufacturer1October 5, 1992000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1September 20, 2004000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1September 20, 2004010api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler, Specification developer1February 17, 1998010api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1September 9, 1997000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1November 25, 1996000api.fda.gov
Trinity Biotech USAJamestown, NY, United StatesManufacturer1September 25, 1992000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Cenogenics Corp.Morganville, NJ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer for export0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.